A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of GLPG0634 (daily for 7 days). Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with midazolam in healthy male subjects will be evaluated.

Key facts

Study ID

NCT01798979

Run by

Lakefront Biotherapeutics NV

People needed

20

Starts

2013-02-01

Expected to finish

2013-04-01

Last updated by the study team

2013-05-07

Who can join

Age: 40 and older, up to 60. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• male, between 40 and 60 years of age, inclusive
• within BMI range 18 to 30 kg/m2, inclusive

You may not qualify if…

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Where it is running

• Covance Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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